BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ORTHO PROVUE

    MDR report key: 5920783 · Received September 1, 2016

    Report

    Report Number
    1056600-2016-00073
    Event Type
    Malfunction
    Date Received
    September 1, 2016
    Date of Event
    August 2, 2016
    Report Date
    September 1, 2016
    Manufacturer
    MICROTYPING SYSTEMS
    Product Code
    KSZ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    MEDICAL TECHNOLOGIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS INSTRUMENT HAS BEEN INVESTIGATED. ON 8-5-16 AN OCD FIELD ENGINEER (FE) ARRIVED AT THE CUSTOMER SITE AND REPLACED THE SYRINGE AND BELT DUE TO WEAR. THE FE INSTALLED MOD 29 CENTRIFUGE SOFTWARE. THE FE CLEANED READER LENS, LEDS AND DIFFUSER. THE FE ADJUSTED READER CAMERA TO 118 SET PASSED (RANGE 101-128) . THE FE RAN WADD DIAG CARD AND READER PASSED. REPAIRS HAVE RETURNED THIS INSTRUMENT TO EXPECTED OPERATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED PROVUE MISREAD ON ANTIBODY SCREENING TEST FOR SAMPLE WITH WEAK REACTIVITY NOTED UPON VISUAL REVIEW OF THE GEL CARD. THE SAMPLE HAD ANTI-D ANTIBODY IDENTIFIED. SAMPLE 2 OF 2. NO INCORRECT RESULTS WERE REPORTED. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    575069 ORTHO PROVUE AUTOMATED BLOOD GROUPING & ANTIBODY TEST SYSTEM KSZ MICROTYPING SYSTEMS 3.1.1

    Patients

    Seq Age Sex Outcome Treatment
    1